agency washington, dc 20460 overview of the epa quality ...epa quality system final overview i...

QualityQuality

United States Office of Environmental EPA/240/R-02/003Environmental Protection Information November 2002Agency Washington, DC 20460

Overview of the EPA QualitySystem for Environmental Data and Technology

EPA Quality System FinalOverview November 2002i

FOREWORD

This document provides a brief summary of EPA’s Quality System for environmental dataand technology for EPA and non-EPA organizations who are not familiar with the system but aresubject to its requirements. It shows where to find detailed information on the requirements andstructure, but does not contain in-depth discussions. For example, this document will help anindividual identify whether their organization needs a Quality Management Plan, and if so, whereto find detailed procedures, specifications, and other information.

EPA’s Quality System is a key component in implementing EPA’s Information QualityGuidelines released October 2, 2002 (see www.epa.gov/oei/quality/guidelines/index.html). Thisdocument provides information on the policies and responsibilities defined in EPA Order 5360.1A2 (May 2000), Policy and Program Requirements for the Mandatory Agency-wide QualitySystem. This document does not change any existing EPA policies or create any newrequirements.

EPA works every day to produce quality information products. The information used inthese products are based on Agency processes to produce quality data, such as the quality systemdescribed in this document. Therefore, implementation of the activities described in this documentis consistent with EPA’s Information Quality Guidelines and promotes the dissemination of qualitytechnical, scientific, and policy information and decisions.

This is one of the EPA Quality System Series documents that describe EPA policies andprocedures for planning, implementing, documenting, and assessing the effectiveness of a qualitysystem. Questions regarding any EPA Quality System Series documents should be directed to:

U.S. EPA Quality Staff (2811R)1200 Pennsylvania Avenue, NWWashington, DC 20460Phone: (202) 564-6830Fax: (202) 565-2441e-mail: [email protected]

Copies of EPA Quality System Series documents may be obtained from the Quality Staff or bydownloading them from the Quality Staff Home Page:

www.epa.gov/quality

This document is valid for a period of up to five years from the official date of publication. After five years, this document shall either be reissued without change, revised, or withdrawnfrom the Quality System Series documentation.

EPA Quality System FinalOverview November 2002ii

EPA Quality System FinalOverview November 2002iii

TABLE OF CONTENTS

Page

1. BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. GOALS AND BENEFITS OF THE EPA QUALITY SYSTEM . . . . . . . . . . . . . . . . . 2

3. EPA QUALITY SYSTEM BASICS AND STRUCTURE . . . . . . . . . . . . . . . . . . . . . . 33.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33.2 Basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33.3 Organizational Structure of the EPA Quality System . . . . . . . . . . . . . . . . . . . . . . 6

3.3.1 EPA Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63.3.2 Non-EPA Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.4 Structural Components of the EPA Quality System . . . . . . . . . . . . . . . . . . . . . . . 73.4.1 Graded Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93.4.2 Policy Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93.4.3 Organization/Program Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123.4.4 Project Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

4. REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144.1 Requirements for EPA Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144.2 Requirements for Non-EPA Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

5. RESPONSIBILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165.1 Agency Senior Management Official for Quality . . . . . . . . . . . . . . . . . . . . . . . . 165.2 Quality and Information Council/Quality Subcommittee . . . . . . . . . . . . . . . . . . 165.3 Office of Environmental Information’s Quality Staff . . . . . . . . . . . . . . . . . . . . . 205.4 National Program Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205.5 Regional Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205.6 Individual Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.6.1 EPA Quality Personnel Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . 205.6.2 EPA Managers and Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215.6.3 EPA Extramural Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

5.7 Non-EPA Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

6. OTHER SOURCES OF INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

7. REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

APPENDIX A. QUALITY SYSTEM TOOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25A.1 Program/Organizational Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

A.1.1 Quality Management Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

EPA Quality System FinalOverview November 2002iv

PageA.1.2 Quality System Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26A.1.3 QA Annual Report and Work Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26A.1.4 Training Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

A.2 Project Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27A.2.1 Systematic Planning and the Data Quality Objectives Process . . . . . . . . 27A.2.2 Quality Assurance Project Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27A.2.3 Standard Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28A.2.4 Technical Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28A.2.5 Data Verification and Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28A.2.6 Data Quality Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

LIST OF FIGURESPage

1. Example EPA Organizations within the EPA Quality System . . . . . . . . . . . . . . . . . . . . . 62. EPA Quality System Components and Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83. The Project Life Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134. Quality Management Responsibilities by Individual . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

LIST OF BOXESPage

1. How to Use this Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12. Important Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43. Examples of Environmental Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54. Regulations Containing Quality-Related Requirements for non-EPA Organizations . . . 115. Quality Management Responsibilities for EPA Organizations . . . . . . . . . . . . . . . . . . . . 17A-1. Quality Management Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

EPA Quality System FinalOverview November 20021

OVERVIEW OF THE EPA QUALITY SYSTEM FOR ENVIRONMENTAL DATA AND TECHNOLOGY

1. BACKGROUND

In order to provide quality products and services, an organization must control itstechnical, administrative, and human factors that affect quality. A quality system is the means bywhich an organization ensures the quality of the products or services it provides and includes avariety of management, technical, and administrative elements such as:

C policies and objectives,C procedures and practices,C organizational authority,C responsibilities, andC accountability.

It provides the framework for planning, implementing, assessing, and improving work performedby an organization and for performing quality assurance (QA) and quality control (QC) activities.

This document summarizes the EPA’s Quality System for environmental data andtechnology for those who are not familiar with the system but are subject to its requirements. Itis intended to be a reference guide for EPA managers and staff who implement the EPA QualitySystem by summarizing the structure (Sections 3.3 and 3.4), requirements (Section 4),responsibilities (Section 5), and tools (Appendix A). This document does not provide detailedinformation on each subject, instead it shows where to find such information. For example, thisdocument will help an individual identify whether their organization needs a QualityManagement Plan, and if so, where to find detailed procedures, examples, and other information. For a description of the topics covered in this document, see Box 1.

Box 1. How to Use this Document

If you are interested in: see Section(s)

A general overview of the EPA Quality System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 and 3

Organizational structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 and 5

Components and tools for implementing the EPA Quality System . . . . . 3.4 and Appendix A

Basic requirements for EPA organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1

Roles and responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Information for non-EPA organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4.2.2, 4.2, and 5.7


This document can also be used by non-EPA organizations (e.g., State, local, and Tribalgovernments; contractors; etc.) to identify the general requirements for their organization(Sections 3.4.2.2, 4.2, and 5.7) as well as components and tools (Appendix A) that can be used tosatisfy these requirements. However, detailed specifications for non-EPA organizations are notdescribed because these specifications can not extend beyond what is contained in the Code ofFederal Regulations or in an individual agreement.

2. GOALS AND BENEFITS OF THE EPA QUALITY SYSTEM

The goal of the Agency-wide Quality System is to ensure that environmental programsand decisions are supported by data of the type and quality needed and expected for theirintended use, and that decisions and applications involving environmental technology aresupported by appropriate quality-assured engineering standards and practices. Effectiveimplementation of the EPA Quality System leads to several benefits including:

• Scientific Data Integrity – EPA will produce data of known and documentedquality and non-EPA organizations will submit data of known and documentedquality to EPA.

• Reduced or Justifiable Resource Expenditures – Resource expenditures can bereduced as planned information collection activities are more closely matched tothe information needs. For example, through systematic planning, only theappropriate type, amount, and quality of data will be collected by EPA, and thosecollecting data on behalf of EPA or to satisfy EPA requirements.

• Effective Management of Internal and External Activities – The quality systemrequires documentation of activities and oversight for evaluation purposes. Thisreduces the potential for waste and abuse.

• Reliable and Defensible Decisions – When the quality of data is known, it ispossible to determine if the data can be used for a specific decision. This reducesthe likelihood of losing challenges to regulations, enforcement actions, permitappeals, etc., resulting from the use of data of uncertain quality.

• Burden Reduction – As EPA better defines the data needed for a specificapplication, the burden on other organizations who are required to collect and/orreport these data may be reduced. Our own internal burden may also be reducedas we become more efficient.

• Continual Improvement – The continual improvement component of the EPAQuality System leads to the development of a better and more responsive QualitySystem and technical system which should result in better products and services.


Overall, successful implementation of the EPA Quality System will reduce the Agency’svulnerabilities in decision making and increase EPA’s credibility by providing the ability to makereliable, timely, cost-effective, and defensible decisions. The consequences of not having asuccessfully implemented quality system include the potential to waste time, money, and otherresources and increase the uncertainty in EPA’s decisions.

3. EPA QUALITY SYSTEM BASICS AND STRUCTURE

3.1 Scope

The EPA Quality System encompasses management and technical activities pertaining tothe planning, implementation, assessment, and improvement of environmental programs withinthe Agency’s scope that involve:

• the collection, evaluation, and use of environmental data, and

• the design, construction, and operation of environmental technology.

Box 2 contains definitions that are useful in understanding the scope of this system; Box 3contains examples of environment programs to which the EPA Quality System applies. The EPAQuality System applies uniformly to EPA organizations and to non-EPA organizations funded byEPA. Section 3.3 describes the organizations that are included within the EPA Quality System.

3.2 Basis

The EPA Quality System is based on ANSI/ASQC E4-1994, Specifications andGuidelines for Quality Systems for Environmental Data Collection and EnvironmentalTechnology Programs. ANSI/ASQC E4 is an American National Standard for qualitymanagement practices for environmental programs involving the collection and evaluation ofenvironmental data and the design, construction, and operation of environmental technologies. This standard provides a basis for planning, implementing, documenting, and assessing aneffective quality system. EPA requires conformance to this standard through internal Orders andthe Code of Federal Regulations (see Section 3.4.2). Copies of the ANSI/ASQC E4 may bepurchased from:

ASQ Quality PressP.O. Box 3005Milwaukee, WI 53201-3005Phone: (800) 248-1946www.asq.org


Box 2. Important Definitionsa

Environmental Programs - activities involving the environment, including but notlimited to: characterization of environmental processes and conditions;environmental monitoring; environmental research and development; laboratoryoperations on environmental samples; and the design, construction, and operationof environmental technologies.

Environmental Data - any measurements or information that describeenvironmental processes, locations, or conditions; ecological or health effects andconsequences; or the performance of environmental technology. For EPA,environmental data include both primary data (i.e., information collected directlyfrom measurements) and secondary/existing data (i.e., data that were collected forother purposes or obtained from other sources, including literature, industrysurveys, models, data bases, and information systems).

Environmental Technology - an all-inclusive term used to describe pollutioncontrol devices and systems, waste treatment processes and storage facilities, andsite remediation technologies and their components that may be utilized to removepollutants or contaminants from or prevent them from entering the environment. Examples include wet scrubbers (air), soil washing (soil), granulated activatedcarbon unit (water), and filtration (air, water). Usually, this term will apply tohardware-based systems; however, it will also apply to methods or techniques usedfor pollution prevention, pollutant reduction, or containment of contamination toprevent further movement of the contaminants, such as capping, solidification orvitrification, and biological treatment.

Quality Assurance (QA) - an integrated system of management activities involvingplanning, implementation, assessment, reporting, and improvement to ensure that aprocess, item, or service is of the type and quality needed. QA is typically appliedby managers or technical personnel assigned to a specific oversight role. ExampleQA activities include technical and management assessments of field and analyticaloperations.

Quality Control (QC) - an overall system of technical activities that measures theperformance of a process, item, or service against defined standards to verify thatthe performance meets the stated requirements. QC is typically applied bytechnical personnel. Example QC activities include the use of control samplesduring sample collection, handling, and analysis, and activities such as data review.

aFrom ANSI/ASQC E4-1994


Box 3: Examples of Environmental Programs

Example environmental programs include but are not limited to:

• Characterize and/or evaluate the states and/or conditions of environmental orecological systems and the health of human populations;

• Characterize and/or evaluate chemical, biological, physical, or radioactiveconstituents in environmental and ecological systems, and their behavior andassociated interfaces in those systems;

• Establish the ambient conditions in air, water, sediments, and soil in terms ofphysical, chemical, radiological, or biological characteristics;

• Determine and/or categorize radioactive, hazardous, toxic, and mixed wastes in theenvironment and to establish their relationships with and/or impact on human healthand ecological systems;

• Quantify and/or monitor the waste and effluent discharges to the environment fromprocesses and operations (e.g., energy generation, metallurgical processes,chemicals production), during either normal or upset conditions (i.e., operatingconditions that cause pollutant or contaminant discharges);

• Develop and/or evaluate environmental technology for waste treatment, storage,remediation, and disposal; pollution prevention; and pollution control and the use ofthe technology to generate and/or collect data (e.g., treatability and pilot studies);

• Map environmental processes and conditions, and/or human health risk data, etc.

(e.g., geographical information system);

• Support enforcement and/or compliance monitoring efforts;

• Develop or evaluate methods for use in the collection, analysis, and use ofenvironmental data;

• Develop and/or evaluate models of environmental processes and conditions anduse models to characterize environmental processes or conditions;

• Develop, revise, or use of information technology and management systemoperations that impact the quality of the results of environmental programs (e.g.,electronic databases with environmental information including data entry, handling,transmission and analysis, and laboratory information management systems); and

• Monitor or address concerns over the occupational health and safety of personnel inEPA facilities (e.g., indoor air quality measurements) and in the field (e.g., chemicaldosimetry, radiation dosimetry).

1Note, not all EPA Offices are shown on Figure 1. See www.epa.gov/epahome/organization.htm for acurrent list of EPA Offices.


3.3 Organizational Structure of the EPA Quality System

3.3.1 EPA Organizations

Because of the diversity (and dispersion) of programs within EPA, the Agency-wideQuality System is decentralized so organizations have individual quality systems that specificallyaddress their needs. As a result, the EPA Quality System is composed of individual qualitysystems developed and implemented by the various EPA Regions, National Program Offices, andthe National Centers and Laboratories in the Office of Research and Development. Theseindividual quality systems are supported by the quality systems of non-EPA organizations whoreceive funding from, and provide data and information to, EPA.

Figure 11 shows the organizational structure for quality management in EPA. Overall,there are more than 40 EPA organizations that maintain quality systems. These organizations areusually at the Regional Office level, at the level immediately below each National Program

EPA

Air &Radiation

Office

Office

Office

Enforcement & Compliance

Assurance

Office

Office

Office

Prevention, Pesticides

& Toxic Substances

Office

Office

Office

Solid Waste &

Emergency Response

Office

Office

Office

Regions

Region 1

Region 2

. . .

Research &

Development

Lab

Center

. . .

Quality and Information Council and

Quality SubCommittee

Water

Office

Office

Office

Env.Information

Office

Office

Office

Quality Staff

Figure 1. Example EPA Organizations within the EPA Quality System


Office, and at the National Center and Laboratory level. Specialized, complex, large, or highly-visible programs (for example, EPA’s Great Lakes National Program) also may have their ownquality systems. Typically, such programs cut across organizational lines and have their ownorganizational infrastructure. The Assistant Administrator for Environmental Information isresponsible for developing and coordinating the EPA Quality System in addition to directing itsimplementation within EPA. This role is performed by the Quality Staff. See Section 5 for adiscussion of the specific responsibilities of each of these organizations.

3.3.2 Non-EPA Organizations

Non-EPA organizations are required to develop and implement quality systems to supporttheir environmental programs and projects funded or regulated by EPA. This quality system maybe part of an existing system for the organization as long as it addresses all of EPA’srequirements. Organizations that may be affected by the EPA Quality System requirementsinclude: other Federal departments and agencies; State, local, and Tribal governments; academicand other non-profit organizations; and commercial business enterprises. Quality managementrequirements are either defined through the Federal Regulations that specify, in general, what anorganization must do to comply with EPA policy, or are negotiated into agreements that are notcovered by the Federal Regulations. See Sections 3.4.2.2 and 4.2 for discussions on the specificregulations and requirements for non-EPA organization.

3.4 Structural Components of the EPA Quality System

Figure 2 illustrates the components to consider when developing an individualizedQuality System. There are 3 types of components in the EPA Quality System:

1. Policy – These components address quality-related policies and regulations that EPAorganizations and non-EPA organizations must address.

2. Organization/Program – These components address the management andimplementation component of the individual Quality System. The components areapplied across an entire organizations (e.g., a Regional Office or a National ResearchLaboratory) or to a specialized, complex, large, or highly-visible programs (for example,EPA’s Great Lakes National Program).

3. Project – These components address the project-specific components that are appliedto individual projects (within an organization or program) to ensure that the projectobjectives are achieved.

Figure 2 also shows some of the quality management tools EPA has developed to assist indeveloping and implementing a quality system. These tools are described in Appendix A.


OR

GA

NIZ

AT

ION

/PR

OG

RA

M

PR

OJE

CT

PO

LIC

Y

Defensible Products and Decisions

EPA Program &Regional Policy

External PoliciesContracts - 48 CFR 46

Assistance Agreements - 40 CFR 30, 31, and 35

Internal EPA PoliciesEPA Order 5360.1EPA Manual 5360

Consensus StandardsANSI/ASQC E4ISO 9000 Series

TechnicalAssessments

IMPLEMENTATIONPLANNING ASSESSMENT

Acquire Data

QA Project Plan

SystematicPlanning

(e.g., DQO Process)

StandardOperating

Procedures

Data QualityAssessment

Data Verification& Validation

Annual Review and Planning (e.g., QA Annual Report

and Work Plan)

System Assessment(e.g., Quality System Audit)

Quality SystemDocumentation

(e.g., Quality Management Plan)

Training/Communication(e.g., Training Plan,

Conferences)

Supporting System Elements(e.g., Procurements,

Computer Hardware/Software)

Figure 2. EPA Quality System Components and Tools


3.4.1 Graded Approach

The development and implementation of a quality system should be based on a “gradedapproach.” This means that the components and tools of a quality system (Figure 2) are appliedaccording to the scope and nature of an organization, program, or project and the intended use ofits products or services. This approach recognizes that a “one size fits all” approach to qualitymanagement is not appropriate and that the quality system of different organizations and programshould (and will) vary according to the specific needs of the organization. For example, thequality expectations of a research program are different from that of a regulatory complianceprogram because the intended use of the products differs.

3.4.2 Policy Components

The policy components of the EPA Quality System consist of:

T Agency-wide policies specific to EPA organizations,

T Agency-wide policies for non-EPA organizations that perform environmentalprograms on behalf of EPA, and

T Organization and program-specific policies for both EPA and non-EPAorganizations. These policies are consistent with one another and are based on thenational consensus standard ANSI/ASQC E4.

3.4.2.1 Agency-wide Internal Policy

Agency-wide policies for EPA organizations are contained in EPA Order 5360.1 A2 andEPA Manual 5360 A1. Together, these documents define the Agency-wide Quality System. Copies of these documents are available at www.epa.gov/quality/tools-pol.html.

EPA Order 5360.1 A2 (May 2000), Policy and Program Requirements for theMandatory Agency-wide Quality System – Establishes the minimum requirements forEPA organizations covered by the mandatory Agency-wide Quality System includingconformance to ANSI/ASQC E4-1994. Contains requirements specific to EPA such asdeveloping Quality Management Plans, ensuring adequate resources, providing training,etc. Describes responsibilities for EPA management, staff, and quality managementpersonnel.

EPA Manual 5360 A1 (May 2000), EPA Quality Manual for Environmental Programs– Known as the Quality Manual. Provides implementation requirements for EPAorganizations covered by the mandatory Quality System defined in EPA Order 5360.1.Addresses the implementation of quality management activities, including inherentlygovernmental functions (i.e., the limitations on the use of non-EPA organizations for


quality-related activities); reporting requirements; requirements for organizations fundedby EPA; requirements for reporting results from applicable environmental programs;Quality System requirements and guidance documents; user-specific quality-relatedguidance; and dispute resolution. Provides details on documenting compliance with EPAOrder 5360.1.

3.4.2.2 Agency-wide External Policy

Quality System policies and requirements for non-EPA organizations funded by EPA arecontained in the Code of Federal Regulations (CFR). There are four basic regulations that applyto extramural agreements (i.e., contracts, grants, and cooperative agreements, as well as any workassignments, delivery orders, or tasks orders that are contained in the above). Box 4 containsinformation on which requirement applies to an individual or organization. Each regulation isdescribed below and the full text is available at www.epa.gov/quality/exmural.html.

48 CFR 46, “Quality Assurance” – Contains requirements for contracts, workassignments, delivery orders, and task orders. Allows Federal agencies to select anational consensus standard as a basis for their quality requirements. EPA usesANSI/ASQC E4 as its basis and requires that offerors/contractors submit a QualityManagement Plan (or equivalent) and a QA Project Plan (or equivalent) to demonstrateconformance to the standard.

40 CFR 30, “Grants and Agreements with Institutions of Higher Education, Hospitalsand Other Non-Profit Organizations” – Contains requirements for organizationsidentified in title. Requires that grantees comply with ANSI/ASQC E4. EPA requiresthat grantees submit a Quality Management Plan (or equivalent) and a QA Project Plan(or equivalent) to demonstrate conformance.

40 CFR 31, “Uniform Administrative Requirements for Grants and CooperativeAgreements to State and Local Governments” – Contains requirements for grants andcooperative agreements to State, local, and Tribal Governments. Requires that granteesdevelop and implement quality-related practices to produce data of adequate quality tomeet project objectives. EPA has issued clarifying language to require grantees tocomply with ANSI/ASQC E4-1994 and submit a Quality Management Plan and QAProject Plans (or equivalents) to demonstrate conformance. This clarifying language isavailable at www.epa.gov/ogd/ quality_ assurance_ requirements.htm and is consistentwith 40 CFR 30.

40 CFR 35, “State and Local Assistance” – Contains program-specific requirements forfinancial assistance agreements to State, local, and Tribal governments. Requires thatgrantees comply with 40 CFR 31.


Box 4. Regulations containing Quality-Related Requirementsfor non-EPA Organizations

ContractCooperativeAgreement Grant*

Inter-AgencyAgreement Agency Mandates

Contractor 48 CFR 46 N/A N/A N/A N/A

Consultant 40 CFR 46 N/A 40 CFR 30 N/A N/A

FederalAgency

N/A N/A N/A Negotiated intoeach agreement

Contained in the individual Federal Regulation

Hospital 48 CFR 46 40 CFR 30 40 CFR 30 N/A Contained in the individual Federal Regulation

Institute of HigherEducation

48 CFR 46 40 CFR 30 40 CFR 30 N/A Contained in the individual Federal Regulation

Local Government 48 CFR 46 40 CFR 30,31, 35

40 CFR 30,31, 35

N/A Contained in the individual Federal Regulation

Non-profitOrganization

48 CFR 46 40 CFR 30 40 CFR 30 N/A Contained in the individual Federal Regulation

Permittees N/A N/A N/A N/A Contained in the Federal Regulation underwhich the permit was issued as well as thespecific requirements contained in the permit

Regulated Entity N/A N/A N/A N/A Contained in the individual Federal Regulation

State Government 48 CFR 46 40 CFR 30,31, 35

40 CFR 30,31, 35


Tribal Government 48 CFR 46 40 CFR 30,31, 35

40 CFR 30,31, 35


*Grants include Performance Partnership Grants and Performance Partnership Agreements.


Quality requirements are negotiated into interagency agreements and consent agreements,and may be included in consent orders. This is done on a case-by-case basis by the EPAorganization sponsoring or overseeing the work. Additional quality requirements may beincluded in Federal regulations. For example, 40 CFR 160.35, “Federal Insecticide, Fungicide,Rodenticide Act,” contains additional quality management requirements specific to this Act.

3.4.2.3 Organizational-specific or Program-specific Policies for both EPA and non-EPA Organizations

Each EPA organization or program integrates the Agency-wide quality policies into itsindividual quality policies, procedures, and practices. These organizations or programs also:

(1) tailor internal policies in their Quality Management Plan (see Appendix A,Section A.1.1) to better meet their organization-specific needs; and

(2) define additional quality-related requirements for non-EPA organizations toensure that program-specific goals and objectives are satisfied. Theserequirements are written into program-specific Federal Regulations or individualextramural agreements.

All program or organization-specific policies must be consistent with the Agency-wide policies.

3.4.3 Organization/Program Components

The organization/program components include management policies and processes thathave broad application across an organization or program. There are four key components: Quality System Documentation; System Assessments; Annual Reviews and Planning; andTraining. Successful implementation of each component is essential to an effective QualitySystem. For each of these components, EPA has developed tools to assist in the implementation. These tools are italicized in the discussion below and described in Section A.1 of Appendix A.

The use of a component or tool should reflect the needs of the organization relative to itsenvironmental programs and the organization’s policy. The Organization/Program componentsshould address the policies and responsibilities that apply to activities that are common to allprojects performed by (or for) the organization or program. For example, an organization’spolicy requiring QA Project Plans along with the process for reviewing and approving thoseplans should be included in the quality system documentation (an Organization/Programcomponent) since the process would apply to all QA Project Plans. The Organization/Programcomponents include:

Quality System Documentation – Documentation that describes the authorities, policies,and procedures specific to an organization. EPA organizations are required to documenttheir quality system in a Quality Management Plan.


Planning

Assessment andImprovement

Productor Decision

Implementationand Oversight

Aquired data w/accompanyingquality-related

information

Statisticalanalysis and

scientificconclusions

Planning documents, performance criteria,Standard Operating

Procedures

Resultsinform future

studies

Figure 3. The Project Life Cycle

System Assessments – Systematic assessments of a program and/or organization’squality system. EPA uses Quality Systems Audits, Management System Reviews, andother assessment techniques to evaluate EPA and supporting organizations. EPAorganizations are required to assess their organization at least annually.

Annual Reviews and Planning – A review of the activities within, and changes to, anorganization's quality system; work accomplished; and the planning of future quality-related activities. Each EPA organization is required to submit a QA Annual Report andWork Plan to document their review and planning.

Training – Education to ensure that all personnel with responsibility for management,data collection activities, or the use of environmental technology have the necessaryskills, knowledge, and proficiency in accordance with their organization’s quality system. EPA organizations are required to document their Training Program in their QualityManagement Plan.

3.4.4 Project Components

These components apply to projects within an organization or program that involveenvironmental data generation, acquisition, and use. Note that projects are not limited to thoseinvolving the collection of environmental measurements; the project components of the EPAquality system also apply to projects involving the use of measurements collected for a differentproject or purpose, produced from models, and compiled from other sources such as data bases orthe literature.

There are three project components– planning, implementation, andassessment – that correspond to the ProjectLife Cycle (see Figure 3) and lead to aspecific product or decision. The projectlife cycle is iterative in nature; eachcomponent feeds back into the others forimprovements. Use of each component iscritical for ensuring that the quality ofenvironmental information can bedetermined and whether the informationcan be used for a specific decision.

For each project component, EPA has developed quality management tools to assist in theimplementation. These tools are italicized in the discussion below and described in Section A.2of Appendix A. Individuals who typically use these tools are identified in Section 5.


Planning: Prospective data users use systematic planning, such as the Data QualityObjectives Process, to develop performance criteria for the data (i.e., the type, quantity,and quality of data needed for a specific purpose), to develop a sampling plan thatsatisfies the criteria, and to determine the level of oversight and quality control activitiesneeded to ensure the criteria are satisfied. The systematic planning results aredocumented in the QA Project Plan or other planning documents.

Implementation and Oversight: Data are acquired according to the approved methodsand procedures documented in the QA Project Plan and Standard Operating Procedures. Oversight is performed using technical audits and assessments (such as product/serviceor process quality audits) to determine if the data are being acquired as required by theQA Project Plan and other planning documents. Actions are taken to correct problemsidentified through the audits or assessments.

Assessment: Project personnel use technical knowledge and statistical methods todetermine whether or not the data meet the user’s needs. The data are formally verifiedand validated to ensure that the measured values are free of gross errors due to proceduralor technical problems and then are analyzed to determine if they meet the performancecriteria documented in the QA Project Plan (data quality assessment). The results of aproject may also be peer reviewed.

Also, an assessment of the overall project may be performed as part of a system assessmentdescribed in Section 3.4.4 at any time during the project life-cycle,

4. REQUIREMENTS

4.1 Requirements for EPA Organizations

There are 11 basic quality management requirements defined in EPA Order 5360.1 for allEPA organizations covered by the EPA Quality System. These requirements are to:

T Conform to the minimum specifications of ANSI/ASQC E4-1994 - see Section3.2 for information about ANSI/ASQC E4-1994;

T Identify a QA Manager and ensure that this individual quality function isindependent from environmental data collection and use - see Section 5.6.1 forresponsibilities of a QA Manager;

T Develop a Quality Management Plan and implement this plan following Agencyapproval - see Section A.1.1 of Appendix A for more information on qualitymanagement plans;

T Provide sufficient resources to implement the quality system;


T Perform an assessment of the effectiveness of the quality system at least annuallyand implement corrective actions based on assessment results in a timely manner -see Section A.1.2 of Appendix A for more information on assessments of qualitysystems;

T Submit an QA Annual Report and Work Plan that summarizes the previous year’sactivities and outlines the work proposed for the current year - see Section A.1.3of Appendix A for more information on the QA Annual Report and Work Plan;

T Implement Agency-wide Quality System requirements in all applicable EPA-funded extramural agreements - see Section 3.4.2.2 for specific requirements;

T Provide appropriate training for all levels of management and staff to assure thatquality-related responsibilities and requirements are understood - see SectionA.1.4 of Appendix A for more information on training;

T Use a systematic planning approach to develop acceptance or performance criteriafor all work covered by the EPA Quality System - see Section A.2.1 of AppendixA for more information on systematic planning;

T Have approved QA Project Plans, or equivalent documents, for all applicableprojects and tasks involving environmental data - see Section A.2.2 ofAppendix A for more information on QA Project Plans; and

T Assess existing data, when used to support Agency decisions or other secondarypurposes, to verify that they are of sufficient quantity and adequate quality fortheir intended use - see Section A.2.3-A.2.5 of Appendix A for more informationon data assessment.

EPA Order 5360.1 also contains program-specific requirements and responsibilities for EPA managers and staff.

4.2 Requirements for Non-EPA Organizations

In general, EPA requires that recipients of funds for work involving environmental datacollection comply with the American National Standard ANSI/ASQC E4-1994, Specificationsand Guidelines for Quality Systems for Environmental Data Collection and EnvironmentalTechnology Programs. In addition, each EPA organization’s Quality Management Plandescribes how the organization will interact with, and any additional requirements for, theorganizations they fund.

2Note: EPA may provide the QA Project Plan (or equivalent documentation). In this case, the fundrecipient would simply implement the Plan provided and not create a new one.


To demonstrate conformance to E4-1994, EPA requires two forms of documentation:

1. Documentation of the organization quality system (usually called a QualityManagement Plan), and

2. Documentation of the application of quality-related activities to anactivity-specific effort (usually called a QA Project Plan)2.

Use of existing quality system documentation, such as that required by the ISO 9000 family ofquality standards, may be an acceptable alternative.

For grants, contracts, and other extramural agreements that consist of a single project ortask, these two documents may be combined into a single document that describes theorganization's quality system and the application of this system to the work performed under thegrant or contract. This can only be done with permission of the EPA QA Manager who willidentify the elements that should be addressed in a combined document.

5. RESPONSIBILITIES

Responsibility for the EPA Quality System is spread across the Agency. Each EPAorganization described below has a specific role and set of responsibilities. Theseresponsibilities are summarized in Box 5 and the relationship between these organizations andindividuals is shown in Figure 4.

5.1 Agency Senior Management Official for Quality

The Assistant Administrator for Environmental Information is the Agency’s SeniorManagement Official for Quality and is responsible for developing and coordinating the Agency-wide Quality System and directing its implementation within EPA. In addition to the Agency-wide Quality responsibilities, the Assistant Administrator for Environmental Information hasresponsibilities specific to this office that are described in Section 5.4.

5.2 Quality and Information Council/Quality Subcommittee

The Quality and Information Council is an advisory group of Agency senior managersthat assists the Assistant Administrator for Environmental Information in the role of SeniorManagement Official for Quality. This Council is supported by the Quality Subcommittee which


Box 5. Quality Management Responsibilities for EPA Organizations1

Asst. AdministratorEnv. Information2 Quality Staff

National Program Offices Regional Offices

QualityManagementPolicies

Issue policiesrecommended by QualityStaff and/or Quality andInformation Council andQuality Subcommittee

Develop for Agency-wideuse

Develop for program – mayapply to Regions

Apply Agency-wide policies

Develop for Region, andState, local, and Tribalgovernments

Apply Agency-wide policies

QualityManagement Plan

Approve EPA plans Review EPA organization’splans

Recommend approval tothe Sr. Official for Quality

Develop and implement foreach program laboratory andorganization

Review/approve the plans ofnon-EPA organizationsfunded by EPA

Develop and implement forRegion

Review/approve the plans ofState, local, and Tribalgovernments, and non-EPAorganizations funded by EPA

QualityManagementProcedures andGuidance

Issue procedures andguidance developed byQuality Staff

Develop for EPA, non-EPAorganizations funded byEPA, and for internal use

Develop for program andactivities delegated toRegions; coordinateimplementation with Regions

Develop for Regions – mayapply to State, local, andTribal governments

Resources forQualityManagementActivities

Recommendimprovements andbalance resourceallocation

Monitor resource allocationacross Agency andhighlight differences andinconsistencies

Provide sufficient resourcesto implement organization’sQuality Management Plan fortheir Office and relatedRegional programs

Provide sufficient resourcesto implement theorganization’s QualityManagement Plan

SystemAssessments andEvaluation

Mandate Agency-widecorrective actions

Periodically review eachEPA organization

Identify Agency-wideproblems and correctiveactions

Perform internalassessments

Assess supportingorganizations (EPA orotherwise)

Perform internalassessments

Assess supportingorganizations (EPA orotherwise), including Stateagencies

Box 5. Quality Management Responsibilities for EPA Organizations1

Asst. AdministratorEnv. Information2 Quality Staff

National Program Offices Regional Offices


QA Annual Reportand Work Plan

Report to EPAAdministrator

Compile information inreport to AA/OEI and EPAAdministrator

Report yearly Report yearly

Communicationand Outreach

Represents EPA onquality practices andissues.

Perform outreach andconsulting

Host monthly conferencecalls, annual National QAConference

Liaison with Quality Staff,EPA QA Managers, andholders of assistanceagreements

Liaison with Quality Staff,other EPA QA Managers andState, local, and Tribalgovernments

Training Issue generic trainingmaterials

Develop generic trainingmaterials

Provide generic training onlimited basis

Develop program-specifictraining

Provide training to programmanagement and staff

Develop Region-specifictraining

Provide training to Regionalmanagement and staff

Ensure training is availablefor State, local, and Tribalgovernments

EmployeeEvaluation(Performance)Standards

Issue general standardspolicy

Develop general standardspolicy

Ensure quality-relatedactivities reflected inperformance standards

Ensure Quality-relatedactivities reflected inperformance standards

1Non-EPA organizations are responsible for developing an EPA-approved Quality Management Plan. This plan should address the otherelements listed on this table with the exception of performance standards.2In conjunction with the Quality and Information Council and Quality Subcommittee.


Regional AdministratorsResponsible for Region's Quality System

Issues Region's QMP

QA RepresentativeCoordinates quality management for AA

State, Local, and Tribal Govts.Contractors, Cooperators, Grantees,

Persons under Env. Statutes, StakeholdersImplements policies and procedures

QMPs, DQOs, QAPPs, SOPs, TAs, DQA

Quality StaffDevelops Agency policy/procedures.Performs oversight of implementationQMPs, QAARWPs, QSAs, Training

Quality SubcommitteeAssists AA/OEI in developing policy

Assistant AdministratorEnvironmental InformationSr. Mgt. Official for QualityIssues Agency policy/procedures

Oversees Agency-wide implementation

QA Manager/DirectorDevelops Office policy & oversees implementation

QMPs, QAARWPs, QSAs, TrainingDQOs, QAPPs, TAs, DQAs

EPA AdministratorResponsible for EPA's Quality System

QMP = Quality Managment PlanQAARWP = QA Annual Reports and Work PlansQSAs = Quality SystemAassessmentsDQO = Data Quality ObjectivesQAPP = Qualitiy Assurance Project PlanSOP = Standard Operating ProcedureTA = Technical AssessmentDQA =Data Quality Assessment/Data Review

QA StaffAssists QA Manager

QMPs, QSAs, Training, DQOs, QAPPs, SOPs, TAs, DQAs

Assistant AdministratorsResponsible for Org.'s Quality System.

Issues Org's QMP

Office, Center, Lab DirectorsResponsible for Org.'s Quality System.

Issues Org's QMP

Project PersonnelImplements policies and procedures

DQOs, QAPPs, SOPs, TAs, DQA

Figure 4. Quality Management Responsibilities by Individual

addresses Agency-wide policy issues in the implementation of the quality program. Both groupsfunction as a forum in which Agency-wide Quality System issues are resolved.

3 Note, organizations within a National Program Office may have programs that are delegated to the EPARegions, States, and Tribal governments, or are supported by Regional, State, or EPA National Research Centersand Laboratories. In this case, the National Program Office must define the quality management responsibilities forthese programs (in their Quality Management Plan) and ensure these responsibilities are addressed.


5.3 Office of Environmental Information’s Quality Staff

The Quality Staff of the Office of Environmental Information supports the AssistantAdministrator for Environmental Information in his/her role as Senior Management Official forQuality. The Staff is the Agency organization assigned the responsibility for developing Agency-wide policy and procedures, coordinating with EPA’s Program Offices, Laboratories, RegionalOffices, and overseeing the implementation of the EPA Quality System. This role includes bothsupporting Agency organizations in developing and implementing their individual QualitySystems and performing assessments on these organizations. Specific responsibilities for theQuality Staff are described in Box 5.

5.4 National Program Offices

The Assistant or Associate Administrator of each National Program Office (including theOffice of Research and Development) is responsible for its quality system (see Section 3.3 forexample EPA Program Offices). Specific responsibilities of the National Program Offices aredescribed in Box 5.3 Each National Program Office has a QA Representative that reports to theAssistant Administrator; advises on quality-related activities; and assists in the planning,implementation, documentation, and assessment of the organization’s quality system. Each lineoffice within a National Program Office typically has a QA Manager or QA Director, QAOfficers, QA Coordinators, and other QA personnel to provide support to the ongoing operationsof the organization.

5.5 Regional Offices

Each Regional Administrator is responsible for the quality system in the Region. Specificresponsibilities for the EPA Regional Offices are shown in Box 5. Each Regional Office has aQA Manager, who advises the Region’s senior management on quality-related activities, andassists in the planning, implementation, documentation, and assessment of the Region’s qualitysystem. Each QA Manager is supported by QA personnel that provide support to the ongoingoperations of the organization.

5.6 Individual Responsibilities

5.6.1 EPA Quality Personnel Responsibilities

EPA organizations are required by EPA Order 5360.1 to identify a QA Manager (or QADirector) who reports on quality issues to the senior management of the organization. This


individual must have sufficient technical and management expertise and authority to conductindependent oversight of and assure the implementation of the organization’s quality system inthe environmental programs of the organization. This individual must function independently ofdirect environmental data generation, model development, or technology development. See Gee(1996) and Pyzdek (1996) for a discussion on roles and activities of a QA Manager for a generalorganization. The responsibilities of a QA Manager and other quality management personnelinclude:

• facilitating the development and maintaining the organization's QualityManagement Plan;

• representing the organization on matters pertaining to quality management;• providing expert assistance on quality-related issues; • developing and implementing a QA Training Program; • reviewing and/or approving quality management documentation; • providing quality management support; and • overseeing and assessing the organization's quality system.

In addition to these general responsibilities, each EPA organization's Quality Management Plandefines specific responsibilities for its QA Manager and other quality management personnel.

5.6.2 EPA Managers and Staff

Quality-related responsibilities for EPA managers and staff are defined in theirorganization’s Quality Management Plan. However, EPA managers are also responsible forensuring that adequate resources are available for quality management activities and thatenvironmental programs comply with EPA Order 5360.1. In addition, both EPA managers andstaff are responsible for ensuring their applicable intramural and extramural programs andactivities comply fully with EPA Order 5360.1 and for assuring that the results of environmentalprograms are of sufficient quantity and adequate quality for their intended use.

5.6.3 EPA Extramural Personnel

Responsibilities for EPA’s Contracting Officers and Contracting Officer’sRepresentatives are contained in the EPA Manual 1900 (EPA 1998), Contracts ManagementManual (epawww.epa.gov/oamintra/policy/cmm.pdf). Quality-related requirements specific tothe EPA Quality System, such as the use of a QA Review Form and criteria for the TechnicalEvaluation Panel, are contained in Chapter 2 of EPA Manual 1900.

EPA’s Assistant Agreement Project Officers and other representatives are responsible forensuring that all quality-related requirements for both proposals and assistance agreements aresatisfied. More information is available on EPA’s Internet (www.epa.gov/ogd) and Intranet(intranet.epa.gov/oinijhhk/ogd.htm).


5.7 Non-EPA Organizations

EPA can not define responsibilities for non-EPA organizations beyond what is containedin the Federal Regulations or in individual agreements (contracts, grants, etc.). Generalrequirements are for non-EPA organizations are described in Section 3.4.2.2; specificrequirements are contained in each individual agreement with EPA.

6. OTHER SOURCES OF INFORMATION

EPA uses several approaches to disseminate quality-related information to qualityprofessionals and to collaborate with other organizations on new initiatives to improve qualitymanagement practices and procedures. These approaches include conference calls, guidance,conferences, Internet sites, and participation in professional societies.

Conference Calls: The EPA QA Managers participate in three monthly conference calls(one for the Regions, one for the Program Offices, and one for the Office of Research andDevelopment) to exchange information and to discuss current issues and activities. Thesecalls are restricted to EPA personnel only and are sponsored by the Quality Staff. EPAProgram Offices may also sponsor conference calls for their quality managementpersonnel.

Quality System Series Documents: EPA publishes a series of documents that describe theAgency-wide policies and procedures for planning, implementing, and assessing theeffectiveness of the EPA Quality System and provide criteria and guidance on satisfyingEPA quality requirements. These documents are called the Quality System Series and areavailable at www.epa.gov/quality/qa_docs.html.

Annual Quality Management Conference: EPA sponsors an annual conference so thatEPA and other quality professionals can share experiences in managing andimplementing their quality systems and quality-related practices. These conferences maybe general in scope or have a specific focus, depending on the needs expressed by thequality management community. The conferences include presentations on nationalissues and feature presentations by EPA and other organizations on technical issues. TheQuality Staff generally offers training in conjunction with these conferences to provide anoptional opportunity for education and professional development in quality concepts andpractices. Information on past and upcoming conferences is available atwww.epa.gov/quality/meeting.html.

Annual Training Conference: EPA sponsors an annual training conference to equipquality management professionals with the knowledge and skills they need to promoteeffective management and implementation of environmental quality systems. Theseconferences offer practical educational opportunities and workshops of varying lengthsthat allow conference attendees to participate in Quality-related training events that are


specific to their organizational needs. The training curriculum includes classes in basicquality-related concepts and principles as well as specialized and advanced courses. Information on upcoming training conferences is available atwww.epa.gov/quality/train.html.

Web Sites: The Agency-wide Quality System web site (www.epa.gov/quality) containsinformation on the EPA Quality System, quality requirements for organizations funded byEPA, training, the Annual Conference, the Quality System Series, and contact persons foreach individual EPA organization. Most Regional Offices and a few program offices alsomaintain web sites with quality-related information. Link to these sites are maintained onthe EPA Quality System web site.

Professional Societies and Standards Development: EPA participates in the qualitymanagement activities of several professional societies and standards developingorganizations including the American Society for Quality, the American Society forTesting and Materials, the American National Standards Institute, and the InternationalOrganization for Standardization.

7. REFERENCES

40 CFR 30, Code of Federal Regulations, “Grants and Agreements With Institutions of HigherEducation, Hospitals, and Other Non-Profit Organizations.”

40 CFR 31, Code of Federal Regulations, “Uniform Administrative Requirements for Grants andCooperative Agreement to State and Local Governments.”

40 CFR 35, Code of Federal Regulations, “State and Local Assistance.”

48 CFR 46, Code of Federal Regulations, “Federal Acquisition Regulations.”

ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for EnvironmentalData Collection and Environmental Technology Programs, American National Standard,January 1995.

EPA Order 1900, Contracts Management Manual, February 1998.

EPA Order 5360.1 A2 (May 2000). Policy and Program Requirements for the MandatoryAgency-wide Quality System, U.S. Environmental Protection Agency, Washington, DC.

EPA Manual 5360 A1 (May 2000). EPA Quality Manual for Environmental Programs, U.S.Environmental Protection Agency, Washington, DC.


Gee, G., Richardson, W., and Wortman, B. (1996). CQM Primer, Quality Council of Indiana,West Terra Haute, IN.

Pyzdek, T. (1996). The Complete Guide to CQM, Quality Publishing, Tuscon, AZ.


APPENDIX A

QUALITY SYSTEM TOOLS

For each components used to develop and implement a Quality System (discussed inSection 3.4), EPA has developed quality management tools to assist in implementation (see BoxA-1 for a summary). The sections below describe these tools and provide references to theQuality System Series documents and other references that discuss the subjects in greater detail. The most recent copies of the Quality System Series are available atwww.epa.gov/quality/qa_docs.html. In addition, web pages containing these documents, alongwith examples, training, and other resources, is identified below for each tool.

A.1 Program/Organizational Tools

A.1.1 Quality Management Plan – www.epa.gov/quality/qmps.html

Purpose: To document an organization’s quality system for planning, implementing,and assessing the effectiveness of activities supporting environmentalprograms. It also documents how, when, and by whom an organization’squality system will be implemented and assessed.

Requirement: Both EPA and non-EPA organizations are required to document theirquality systems in a Quality Management Plan (or equivalent).

References: EPA Manual 5360 A1 (May 2000). EPA Quality Manual forEnvironmental Programs, U.S. Environmental Protection Agency,Washington, DC. Chapter 3 (EPA Only)

EPA Requirements for Quality Management Plans (QA/R-2) (2000).EPA/240/B-01/002, U.S. Environmental Protection Agency, Office ofEnvironmental Information.

Box A-1. Quality Management Tools

Program/Organization Tools

• Quality Management Plans • Quality System Audits• QA Annual Report and Work Plan• QA Training Program

Project Tools

• The Data Quality Objectives Process• QA Project Plans• Standard Operating Procedures• Technical Assessments• Data Validation and Verification• Data Quality Assessment


MacLean, G. E. (1993). Documenting Quality for ISO 9000 and OtherIndustry Standards, ASQ Quality Press, Milwaukee, WI.

A.1.2 Quality System Audits – www.epa.gov/quality/qsas.html

Purpose: To verify, by examination and evaluations of objective evidence, thatapplicable elements of the quality system are appropriate and have beendeveloped, documented, and effectively implemented in accordance and inconjunction with specified requirements (Smith and Russell, 1997).

Requirement: EPA organizations are required to assess their quality systems on at leastan annual basis using quality system audits or other assessment processes. The Quality Staff also performs periodic audits of EPA organizations todetermine the effectiveness of their quality systems.

References: Guidance on Assessing Quality Systems (G-3) (2002). Peer Review Draft,U.S. Environmental Protection Agency, Office of EnvironmentalInformation.

Smith, J. L. and Russell, J. P. (1997). The Quality Audit Handbook, ASQQuality Press, Milwaukee, WI..

A.1.3 QA Annual Report and Work Plans – www.epa.gov/quality/qaarwps.html

Purpose: To document an EPA organization’s previous year’s quality-relatedactivities and those planned for the current year, including current andplanned resources for the management and implementation of quality-related activities, training, accomplishments, and assessments.

Requirement: EPA organizations are required to submit a QA Annual Report and WorkPlan to the Assistant Administrator of the Office of EnvironmentalInformation every year.

References: EPA Manual 5360 A1 (May 2000). EPA Quality Manual forEnvironmental Programs, U.S. Environmental Protection Agency,Washington, DC. Chapter 4.

A.1.4 Training Program – www.epa.gov/quality/training.html

Purpose: To assure that all personnel have the necessary skills in order to effectivelyaccomplish their work and that quality management responsibilities andrequirements are understood at every stage of project implementationthroughout the Agency.


Requirement: EPA organizations are required to provide training, for all levels ofmanagement and staff, to assure that quality-related responsibilities andrequirements are understood at every stage of project implementation;

References: Guidance for Developing a Training Program for Quality Systems(QA/G-10) (2000). EPA/600/B-00/004, U.S. Environmental ProtectionAgency, Office of Environmental Information.

A.2 Project Components

A.2.1 Systematic Planning and the Data Quality Objectives Process –www.epa.gov/quality/dqos.html

Purpose: To identify the expected outcome of the project, the technical goals, thecost and schedule, and the acceptance criteria for the final result before aproject begins. EPA recommends using the Data Quality ObjectivesProcess when data are being used to select between two opposingconditions, such as determining compliance with a standard.

Requirement: EPA organizations must use a systematic planning process to developacceptance or performance criteria for the collection, evaluation, or use ofenvironmental data.

References: Guidance for the Data Quality Objectives Process (QA/G-4) (2000)EPA/600/R-96/055, U.S. Environmental Protection Agency, Office ofEnvironmental Information.

The Data Quality Objectives Process for Hazardous Waste Sites(QA/G-4HW) (2000). EPA/600/R-00/007, U.S. Environmental ProtectionAgency, Office of Environmental Information.

A.2.2 Quality Assurance Project Plans – www.epa.gov/quality/qapps.html

Purpose: To document performance criteria and the project-specific plan forobtaining the type, quality, and quantity of data needed for a specific use.

Requirement: An EPA-approved QA Project Plan (or equivalent) is required for allprojects and tasks involving environmental data.

References: EPA Manual 5360 A1 (May 2000). EPA Quality Manual forEnvironmental Programs, U.S. Environmental Protection Agency,Washington, DC. Chapter 5 (EPA Only)


EPA Requirements for Quality Assurance Project Plans (QA/R-5) (2001). EPA/240/B-01/003, U.S. Environmental Protection Agency, Office ofEnvironmental Information.

Guidance for Quality Assurance Project Plans (QA/G-5) (1998). EPA/600/R-98/018, U.S. Environmental Protection Agency, Office ofEnvironmental Information. Office of Research and Development.

A.2.3 Standard Operating Procedures – www.epa.gov/quality/sops.html

Purpose: To document the procedures necessary to carry out routine or repetitiveadministrative and technical activities.

Requirement: As Applicable.

References: Guidance for the Preparation of Standard Operating Procedures forQuality-Related Documents (QA/G-6) (2001). EPA/240/B-01/004, U.S.Environmental Protection Agency, Office of Environmental Information.

A.2.4 Technical Audits – www.epa.gov/quality/dqa.html

Purpose: To provide a systematic independent technical examination of a project todetermine if a data collection activity is being conducted as planned andproducing data and information of the type and quality specified in the QAProject Plan. Examples of technical audits include technical systemaudits, readiness reviews, surveillance, etc.


References: Guidance on Technical Audits and Related Assessments for EnvironmentalData Operations (QA/G-7) (2000). EPA/600/R-99/080, U.S.Environmental Protection Agency, Office of Environmental Information.

A.2.5 Data Verification and Validation – www.epa.gov/quality/vandv.html

Purpose: To determine if data has been collected in accordance to the QA ProjectPlan with respect to compliance, correctness, consistency, andcompleteness and to evaluate the technical usability of the data withrespect to the planned objectives or intention of the project.



References: Guidance on Environmental Data Verification and Validation (G-8)(2001). Peer Review Draft, U.S. Environmental Protection Agency,Office of Environmental Information.

Data Validation Functional Guidelines for Evaluating EnvironmentalAnalyses (1996). U.S. Environmental Protection Agency, Region I, EPA-New England.

A.2.6 Data Quality Assessment – www.epa.gov/quality/dqa.html

Purpose: To provide a scientific and statistical assessment to determine whetherdata are of the right type, quality, and quantity to achieve the objectives ofa project.


References: Guidance for Data Quality Assessment: Practical Methods for DataAnalysis (QA/G-9) (2000). EPA/600/R-96/084, U.S. EnvironmentalProtection Agency, Office of Environmental Information.

Bibliography of References for Assessing Secondary Data (2000). Draft,U.S. Environmental Protection Agency.